K-number	DEN240029
Device name	Healgen Rapid Check COVID-19/Flu A&B Antigen Test
Applicant	Healgen
Product code	SCA
Device class	Class II
Decision date	Oct 7, 2024
Decision	Not Substantially Equivalent
Regulation	866.3987

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View the full FDA submission: accessdata.fda.gov

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Healgen Rapid Check COVID-19/Flu A&B Antigen Test

Everything you need for a 510(k) submission. Nothing you don't.